Trial Outcomes & Findings for Serial Assessment of Body Fat Accrual in Very Preterm Infants (NCT NCT03575897)

NCT ID: NCT03575897

Last Updated: 2025-03-19

Results Overview

Percent body fat estimated by air displacement plethysmography

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: NA
• Target enrollment: 50 participants
• Primary outcome timeframe: Assessed at 3 months of corrected age
• Results posted on: 2025-03-19

Participant Flow

Participant milestones

Measure	Intervention Group Infants randomly assigned to the intervention group will undergo serial measurements of infant body composition during their hospitalization. This information about infant body composition will be known to the clinicians caring for them (including reference data). Assessment of infant body composition: Serial assessments of infant body composition with air displacement plethysmography in very preterm infants will occur in the first 14 days after birth (baseline measure), at 32 weeks postmenstrual age (PMA), and at 36 weeks PMA or hospital discharge (whichever occurs first)	Control Group Infants randomly assigned to the control group will also undergo serial measurements of infant body composition during their hospitalization, but this information will not be available to the clinicians caring for them. Assessment of infant body composition: Serial assessments of infant body composition with air displacement plethysmography in very preterm infants will occur in the first 14 days after birth (baseline measure), at 32 weeks postmenstrual age (PMA), and at 36 weeks PMA or hospital discharge (whichever occurs first)
Overall Study STARTED	25	25
Overall Study COMPLETED	13	12
Overall Study NOT COMPLETED	12	13

Reasons for withdrawal

Measure	Intervention Group Infants randomly assigned to the intervention group will undergo serial measurements of infant body composition during their hospitalization. This information about infant body composition will be known to the clinicians caring for them (including reference data). Assessment of infant body composition: Serial assessments of infant body composition with air displacement plethysmography in very preterm infants will occur in the first 14 days after birth (baseline measure), at 32 weeks postmenstrual age (PMA), and at 36 weeks PMA or hospital discharge (whichever occurs first)	Control Group Infants randomly assigned to the control group will also undergo serial measurements of infant body composition during their hospitalization, but this information will not be available to the clinicians caring for them. Assessment of infant body composition: Serial assessments of infant body composition with air displacement plethysmography in very preterm infants will occur in the first 14 days after birth (baseline measure), at 32 weeks postmenstrual age (PMA), and at 36 weeks PMA or hospital discharge (whichever occurs first)
Overall Study Lost to Follow-up	12	13

Baseline Characteristics

Serial Assessment of Body Fat Accrual in Very Preterm Infants

Baseline characteristics by cohort

Measure	Intervention Group n=25 Participants Infants randomly assigned to the intervention group will undergo serial measurements of infant body composition during their hospitalization. This information about infant body composition will be known to the clinicians caring for them (including reference data). Assessment of infant body composition: Serial assessments of infant body composition with air displacement plethysmography in very preterm infants will occur in the first 14 days after birth (baseline measure), at 32 weeks postmenstrual age (PMA), and at 36 weeks PMA or hospital discharge (whichever occurs first)	Control Group n=25 Participants Infants randomly assigned to the control group will also undergo serial measurements of infant body composition during their hospitalization, but this information will not be available to the clinicians caring for them. Assessment of infant body composition: Serial assessments of infant body composition with air displacement plethysmography in very preterm infants will occur in the first 14 days after birth (baseline measure), at 32 weeks postmenstrual age (PMA), and at 36 weeks PMA or hospital discharge (whichever occurs first)	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	31 Weeks n=5 Participants	30 Weeks n=7 Participants	30 Weeks n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	14 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	11 Participants n=7 Participants	26 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants

PRIMARY outcome

Timeframe: Assessed at 3 months of corrected age

Percent body fat estimated by air displacement plethysmography

Outcome measures

Measure	Intervention Group n=12 Participants Infants randomly assigned to the intervention group will undergo serial measurements of infant body composition during their hospitalization. This information about infant body composition will be known to the clinicians caring for them (including reference data). Assessment of infant body composition: Serial assessments of infant body composition with air displacement plethysmography in very preterm infants will occur in the first 14 days after birth (baseline measure), at 32 weeks postmenstrual age (PMA), and at 36 weeks PMA or hospital discharge (whichever occurs first)	Control Group n=13 Participants Infants randomly assigned to the control group will also undergo serial measurements of infant body composition during their hospitalization, but this information will not be available to the clinicians caring for them. Assessment of infant body composition: Serial assessments of infant body composition with air displacement plethysmography in very preterm infants will occur in the first 14 days after birth (baseline measure), at 32 weeks postmenstrual age (PMA), and at 36 weeks PMA or hospital discharge (whichever occurs first)
Infant Body Composition	21 percentage of body fat Standard Deviation 4	19 percentage of body fat Standard Deviation 6

SECONDARY outcome

Timeframe: Birth to 3 months of corrected age

Weekly weight gain in grams

Outcome measures

Measure	Intervention Group n=13 Participants Infants randomly assigned to the intervention group will undergo serial measurements of infant body composition during their hospitalization. This information about infant body composition will be known to the clinicians caring for them (including reference data). Assessment of infant body composition: Serial assessments of infant body composition with air displacement plethysmography in very preterm infants will occur in the first 14 days after birth (baseline measure), at 32 weeks postmenstrual age (PMA), and at 36 weeks PMA or hospital discharge (whichever occurs first)	Control Group n=12 Participants Infants randomly assigned to the control group will also undergo serial measurements of infant body composition during their hospitalization, but this information will not be available to the clinicians caring for them. Assessment of infant body composition: Serial assessments of infant body composition with air displacement plethysmography in very preterm infants will occur in the first 14 days after birth (baseline measure), at 32 weeks postmenstrual age (PMA), and at 36 weeks PMA or hospital discharge (whichever occurs first)
Growth	8 grams/kg/day Interval 7.0 to 9.0	9 grams/kg/day Interval 7.0 to 9.0

SECONDARY outcome

Timeframe: 3 months of corrected age

Population: 2 infants in the control group did not have a length measurement at 3 months of corrected age

Length in cm at 3 months of corrected age

Outcome measures

Measure	Intervention Group n=13 Participants Infants randomly assigned to the intervention group will undergo serial measurements of infant body composition during their hospitalization. This information about infant body composition will be known to the clinicians caring for them (including reference data). Assessment of infant body composition: Serial assessments of infant body composition with air displacement plethysmography in very preterm infants will occur in the first 14 days after birth (baseline measure), at 32 weeks postmenstrual age (PMA), and at 36 weeks PMA or hospital discharge (whichever occurs first)	Control Group n=10 Participants Infants randomly assigned to the control group will also undergo serial measurements of infant body composition during their hospitalization, but this information will not be available to the clinicians caring for them. Assessment of infant body composition: Serial assessments of infant body composition with air displacement plethysmography in very preterm infants will occur in the first 14 days after birth (baseline measure), at 32 weeks postmenstrual age (PMA), and at 36 weeks PMA or hospital discharge (whichever occurs first)
Length	59 cm Interval 56.0 to 60.0	60 cm Interval 57.0 to 62.0

SECONDARY outcome

Timeframe: 3 months of corrected age

Head circumference in cm at 3 months of corrected age

Outcome measures

Measure	Intervention Group n=12 Participants Infants randomly assigned to the intervention group will undergo serial measurements of infant body composition during their hospitalization. This information about infant body composition will be known to the clinicians caring for them (including reference data). Assessment of infant body composition: Serial assessments of infant body composition with air displacement plethysmography in very preterm infants will occur in the first 14 days after birth (baseline measure), at 32 weeks postmenstrual age (PMA), and at 36 weeks PMA or hospital discharge (whichever occurs first)	Control Group n=10 Participants Infants randomly assigned to the control group will also undergo serial measurements of infant body composition during their hospitalization, but this information will not be available to the clinicians caring for them. Assessment of infant body composition: Serial assessments of infant body composition with air displacement plethysmography in very preterm infants will occur in the first 14 days after birth (baseline measure), at 32 weeks postmenstrual age (PMA), and at 36 weeks PMA or hospital discharge (whichever occurs first)
Head Circumference	40 cm Interval 39.0 to 42.0	41 cm Interval 40.0 to 42.0

SECONDARY outcome

Timeframe: 3 months of corrected age

Weight and height at 3 months of corrected age combined to report BMI in kg/m^2

Outcome measures

Measure	Intervention Group n=13 Participants Infants randomly assigned to the intervention group will undergo serial measurements of infant body composition during their hospitalization. This information about infant body composition will be known to the clinicians caring for them (including reference data). Assessment of infant body composition: Serial assessments of infant body composition with air displacement plethysmography in very preterm infants will occur in the first 14 days after birth (baseline measure), at 32 weeks postmenstrual age (PMA), and at 36 weeks PMA or hospital discharge (whichever occurs first)	Control Group n=12 Participants Infants randomly assigned to the control group will also undergo serial measurements of infant body composition during their hospitalization, but this information will not be available to the clinicians caring for them. Assessment of infant body composition: Serial assessments of infant body composition with air displacement plethysmography in very preterm infants will occur in the first 14 days after birth (baseline measure), at 32 weeks postmenstrual age (PMA), and at 36 weeks PMA or hospital discharge (whichever occurs first)
Body Mass Index	5 kg/m^2 Interval 4.0 to 6.0	6 kg/m^2 Interval 5.0 to 6.0

SECONDARY outcome

Timeframe: Assessed at 36 weeks of postmenstrual age or hospital discharge (whichever occurs first)

Percent body fat estimated by air displacement plethysmography

Outcome measures

Measure	Intervention Group n=18 Participants Infants randomly assigned to the intervention group will undergo serial measurements of infant body composition during their hospitalization. This information about infant body composition will be known to the clinicians caring for them (including reference data). Assessment of infant body composition: Serial assessments of infant body composition with air displacement plethysmography in very preterm infants will occur in the first 14 days after birth (baseline measure), at 32 weeks postmenstrual age (PMA), and at 36 weeks PMA or hospital discharge (whichever occurs first)	Control Group n=17 Participants Infants randomly assigned to the control group will also undergo serial measurements of infant body composition during their hospitalization, but this information will not be available to the clinicians caring for them. Assessment of infant body composition: Serial assessments of infant body composition with air displacement plethysmography in very preterm infants will occur in the first 14 days after birth (baseline measure), at 32 weeks postmenstrual age (PMA), and at 36 weeks PMA or hospital discharge (whichever occurs first)
Infant Body Composition	14 percentage of body fat Standard Deviation 5	14 percentage of body fat Standard Deviation 3

OTHER_PRE_SPECIFIED outcome

Timeframe: Birth to 3 months of corrected age

Determined by molecular analyses of bacteria in fecal samples

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Birth to 3 months of corrected age

Determined by molecular analyses of serum samples

Outcome measures

Outcome data not reported

Adverse Events

Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ariel Salas

University of Alabama at Birmingham

Phone: 205-934-4680

Email: asalas@peds.uab.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place